MAUDE Adverse Event Report: PRODUCTOS MEDLINE S.A. DE C.V. MEDLINE; NEEDLE, QUINCKE, 22GX5" (DIV29)

Catalog Number	PAIN8023
Medical Device Problem Code	Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On (b)(6) 2026, as the tech was opening the needle to put it on the sterile tray, the package ripped about halfway down the package causing the needle to either touch the outside packaging or their hand.After this action occurred another needle had to be opened so that there was no risk for adding a contaminated needle to the sterile field.There was no patient, and no death, injury, follow-up care, medical, and/or surgical intervention or treatment required.
Event or Problem Description
The package tears about halfway making it hard to slide the needle out or it contaminates.
Additional Manufacturer Narrative
Added information to h6 (b) investigation type: 3331, 4121, 4110, and 4111, but no change to investigation findings or conclusion.

• Brand Name: MEDLINE
• Common Device Name: NEEDLE, QUINCKE, 22GX5" (DIV29)
• Manufacturer (Section D): PRODUCTOS MEDLINE S.A. DE C.V.; blvd world trade center 106; nuevo laredo, IL 88285 ; MX 88285
• Manufacturer Contact: lauren glaeser ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24876545
• Report Number: 1417592-2026-00433
• Device Sequence Number: 15728476
• Product Code: BSP
• UDI-Device Identifier: 10884389848258
• UDI-Public: 10884389848258
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K110194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: PAIN8023
• Device Lot Number: 25LBH112
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2026
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 04/14/2026
• Supplement Report FDA Received Date: 05/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown